Qureos Mentor

Hydrogen Group

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 Location:
 
 San Diego, CA - Onsite
 
 
 
 Schedule:
 
 Standard Office Hours
 
 
 
 Duration: 3-
 
 Month Contract
 
 
 
 Pay range:
 
 $40.00 - $44.00 per hour
 
 
 
 This Quality Engineering position supports manufacturing and product quality activities within the Manufacturing/Operations (Mfg/Ops) Quality organization. The role focuses on sustaining manufacturing, continuous improvement, capacity expansion, and process/product validation. It involves cross-functional collaboration and application of regulatory standards (21 CFR 820, ISO 13485, etc.) to ensure product and process quality in a regulated environment.
 
 
 
 Responsibilities
 
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 Support product lifecycle quality engineering.
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 Assist manufacturing with validation planning and transfer.
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 Manage non-conformance and CAPA processes.
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 Participate in technical discussions and risk-based decisions.
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 Review equipment onboarding, calibration, and maintenance for GMP compliance.
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 Review and ensure compliance of change control documentation.
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 Identify and close compliance gaps efficiently and effectively.
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 Use risk-based approaches for issue resolution.
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 Ensure manufacturing processes comply with FDA/ISO requirements.
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 Analyze and report quality data; develop data-driven recommendations.
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 Provide updates and escalate issues as needed.
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 Collaborate with cross-functional teams across multiple sites.
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 Perform other assigned quality-related duties.
 
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 </ul>
 Desired Background
 
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 Education
 
 : Bachelor's degree in an engineering or scientific field.
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 Experience
 
 :
 <ul>
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 2-4 years in quality assurance within a regulated industry.
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 In-vitro diagnostic manufacturing experience preferred.
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 Experience with quality systems (CAPA, NC, Change Management), PLM, ERP, MES tools.
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 Familiarity with nanoimprint lithography/surface activation chemistry is a plus.
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 </ul>
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 Skills
 
 :
 <ul>
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 Strong communication, problem-solving, and organizational skills.
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 Collaboration with cross-functional and global teams.
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 Ability to manage change and make compliance/business trade-off decisions.
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 Proficient in data analysis and quality improvement methodologies.
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 Knowledge of applicable regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD, MDD, CMDR).
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 </ul>
 </li>
 </ul>
 
 
 
 
 
 
 ...
 
 
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Quality Engineer II - San Diego, CA

Join Hydrogen Group and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Hydrogen Group

ABOUT_COMPANY

Quality Engineer II - San Diego, CA